BEUDAMED
    FDA Recall Open, Classified

    Medtronic HVAD Pump Implant Kits

    Recall: Z-2478-2021 · Initiated August 6, 2021

    Recall

    Recall Number
    Z-2478-2021
    Event Number
    88541
    Firm
    Heartware, Inc.
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 6, 2021
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    Description

    Medtronic HVAD Pump Implant Kits

    Reason

    There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.

    Action

    Beginning 10-Aug-2021 (US), and no later than 17-Aug-2021 (OUS), Medtronic initiated a Global notification to inform HVAD clinicians (following physicians and VAD Coordinators at HVAD accounts) who are currently treating patients implanted with the HVAD system about the potential for difficulty in pulling back the HVAD Pump Driveline cover for drivelines that have received a strain relief repair. In the United States, beginning 10-Aug-2021, an Urgent Medical Device Notice, was delivered to following physicians and VAD Coordinators, who are currently caring for an HVAD patient, via UPS 2-day delivery as well as through verbal and in person follow ups from the Medtronic field staff. Also, in the United States, on 17-Aug-2021, Medtronic sent a notification to active HVAD Patients in the U.S. according to their registered contact information via UPS 2-day delivery to make them aware of the potential for this issue and to reinforce precautions in the IFU and Patient Manual cautioning against selfrepairing the HVAD equipment. Outside of the United States, beginning 10-Aug-2021 and no later than 17-Aug-2021, a formal FCA notification will be delivered to VAD Coordinators and following physicians who according to Medtronic records are treating patients implanted with an HVAD system. This letter will be delivered using locally approved methods. Confirmation of the communication will be received via locally approved methods.

    Distribution

    Distribution throughout the US. Also distribution in ARGENTINA Armenia, Australia, Austria, BELGIUM, BRAZIL, CANADA, CHILE, Colombia, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, Germany, GREECE HONG KONG, HUNGARY, INDIA, ISRAEL, Italy, JAPAN, Kazakhstan, Korea, KUWAIT, Latvia, LEBANON, LITHUANIA, LUXEMBOURG, Macedonia, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, Poland, ROMANIA, SAUDI ARABIA, Serbia, Singapore, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan, TURKEY, Ukraine, United Arab Emirates, United Kingdom, VIETNAM

    Quantity

    11851 (potentially active, US); 1995 (active, US)